PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
Purpose
This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays. The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC. Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.
Conditions
- Breast Cancer
- Residual Disease
- Triple Negative Breast Cancer (TNBC)
- Stage II/III
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Written informed consent was obtained to participate in the study, and HIPAA authorization for the release of personal health information. - Participant is willing and able to comply with study procedures based on the judgment of the investigator. - Age ≥ 18 years at the time of consent. - Histological confirmation of TNBC defined by ER/PR <10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative. - Stage II/III TNBC treated with neoadjuvant systemic therapy AND have residual disease defined as RCB II/III at time of surgery. - Baseline staging scans at the discretion of the treating physician and demonstrate no evidence of metastatic disease. - The participant must have archival diagnostic tissue and/or surgical resection tissue Available. - Participants are willing and able to comply with study procedures based on the judgment of the investigator.
Exclusion Criteria
• Participants are pregnant or breastfeeding.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Patients with higher residual cancer burden |
Participants with stage II/III triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence. |
|
Recruiting Locations
Chapel Hill, North Carolina 27514
More Details
- Status
- Recruiting
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Detailed Description
Despite treatment advances, patients with II/III triple negative breast cancer (TNBC) residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence. Furthermore, early detection of relapse risk, when the residual disease burden is micrometastatic (defined here as undetectable by standard cross-sectional imaging), provides a chance for disease eradication whereas macrometastatic disease (i.e., detectable on standard cross-sectional imaging) is generally considered to be non-curable. There are no standard of care (SOC) surveillance strategies for early detection of micrometastatic disease in high-risk TNBC beyond clinical monitoring. Detecting molecular residual disease (MRD) is a promising approach to identifying patients at increased risk of recurrence after definitive therapy, who may benefit from the escalation of their treatment and remain potentially curable with effective systemic therapy.